Mitoquinone mesylate in Amyotrophic Lateral Sclerosis: NCT06429059 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Completed
Recruitment status
not reported
Planned enrollment
2025-05-22
Primary-completion proxy
Executive view
NCT06429059 evaluates Mitoquinone mesylate in Amyotrophic Lateral Sclerosis. The disclosed sponsor is Duke University, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is ALS Functional Rating Scale, Revised (ALSFRS-R), assessed over baseline and at each of the subsequent 9 telephone or in person visits (approximately 9 months).
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT06429059 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Amyotrophic Lateral Sclerosis landscape. Drug & Asset MCP drug_fetch was queried for Mitoquinone mesylate, while Company & Deal Intelligence MCP organization_fetch was queried for Duke University.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT06429059 | Mitoquinone mesylate | Phase 2 / Completed | Duke University | United States | ALS Functional Rating Scale, Revised (ALSFRS-R) baseline and at each of the subsequent 9 telephone or in person visit… | 2025-05-22 |
| NCT06665165 | AMX-0114 | Phase 1 / Recruiting | Amylyx Pharmaceuticals, Inc. | Canada, United States | Evaluate the safety and tolerability of AMX0114 in adult participants living with ALS Day 1 - Day 145 (End of Study) | 2027-02-01 |
| NCT06658977 | Abacavir sulfate/Dolutegravir sodium/Lamivudine | Phase 3 / Terminated | Macquarie University | Australia | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). Duration of the study plus 7 days | 2025-06-03 |
| NCT06656702 | Psilocybin | Early Phase 1 / Recruiting | The Johns Hopkins University | United States | Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment 6 months | 2027-01-30 |
| NCT06643481 | VHB937 | Phase 2 / Status not reported | Novartis Pharmaceuticals | United States, United Kingdom, Switzerland, Spain, Canada, Sweden, South Korea, Netherlands, Belgium, Ireland, China, Poland, Denmark, Italy, France, Australia, Germany | The composite of PAV-free survival and change in ALSFRS-R. Analysis method: Combined Assessment of Function and Surviva… Baseline to DB Week 40 | 2026-06-23 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT06429059 is a Phase 2, completed study with not reported planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “ALS Functional Rating Scale, Revised (ALSFRS-R)” over “baseline and at each of the subsequent 9 telephone or in person visits (approximately 9 months).” The retrieved endpoint description is: A quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant to people living with ALS.The ALSFRS-R declines linearly with time over a wide range during the course of ALS and it has been validated for telephone use..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
0 recent result records were selected as contextual evidence for Amyotrophic Lateral Sclerosis. These records do not establish direct evidence for NCT06429059 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Mitoquinone mesylate is indexed as Small molecule drug with HIF-1α biology and a global stage of Phase 2/3. The asset profile lists Antipodean (UK) Ltd. as an originator or developer.
Duke University is indexed in an unreported country with the website https://www.dukeems.org. Duke University is a private research university providing undergraduate and postgraduate education in medicine and other disciplines. The record lists 65 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Mitoquinone mesylate is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT06429059
Protocol source: https://clinicaltrials.gov/study/NCT06429059
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 15 October 2026.
Mitoquinone mesylate in Amyotrophic Lateral Sclerosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes ALS Functional Rating Scale, Revised (ALSFRS-R) and 2025-05-22 the leading decision points.
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